Archives: Agenda

• Understanding how multiple systems increase burden for sites and study teams
• Identifying where technology slows down rather than supports trial delivery
• Simplifying workflows across platforms to improve adoption and efficiency
• Reducing friction without removing valuable data and insights

Moderator

Kamil Sitarz, Chief Operating Officer, Ryvu Therapeutics

• Explore what becomes possible when clinical data and decisions are connected across study design, country strategy, feasibility, and site selection
• Hear the Novo Nordisk + H1 story and how the organizations are working together toward a more connected clinical development ecosystem
• Learn how to move beyond fragmented systems, spreadsheets, and data sources toward a trusted foundation that helps teams make faster, more informed decisions
• Discover how connecting sponsor intelligence with site-level insights and feedback can strengthen feasibility and site selection while reducing disconnects across the trial lifecycle
• See why connected, mastered data is critical to unlocking the potential of AI in clinical development, and why the future requires more than another point solution

• Identify where Nordic R&D innovation is concentrating across therapy areas, development stages and emerging modalities
• Compare Denmark, Sweden, Finland and Norway to reveal distinct innovation profiles and emerging areas of specialisation
• Benchmark Nordic R&D against the global pipeline to identify where the region is over-indexing and which therapeutic areas and emerging modalities could shape the next wave of drug development

• How patient centered digital measures can capture meaningful changes in health and daily life that traditional, episodic clinical assessments may miss
• How continuous, real-world wearable data can help assess whether improvements during standardized in-clinic tests translate into meaningful changes in patients’ daily live
• Real world case examples demonstrating how fit for purpose digital measures can reveal treatment signals, functional changes, and patient relevant outcomes that standard approaches may not fully capture
• Why successful patient-centered digital measurement requires thoughtful study design, fit-for-purpose algorithms, continuous compliance monitoring, and high-quality data
• Practical guidance for advancing digital measures from exploratory use toward clinically meaningful endpoints while maintaining patient relevance throughout clinical development

• Exploring why, in fully outsourced clinical trial models, visibility across data systems can be less a technology question than a process one
• Understanding where data signals can fall through the gaps when multiple CROs and vendors have their own internal processes, review cadences and timelines
• Case study: a pharmacokinetic protocol deviation that never reached the sponsor because it fell between chairs in the communication chain
• Case study: a screen failure cleaning exercise where a site misinterpretation of instructions led to an irreconcilable discrepancy
• Exploring how stronger oversight frameworks and clearer agreement on what is expected, and from whom, could prevent these issues
• Asking what we should be considering before adopting a new digital tool – recognising that a tool can integrate systems, but not always processes

• Sharing practical examples of what has worked (and what hasn’t)
• Highlighting key challenges and how to overcome them
• Comparing tools in terms of ease of implementation, cost, and impact for smaller teams
• Exploring which solutions are realistically adoptable within limited resources and existing systems

• Exploring why protocol amendments, slow enrolment and late feasibility surprises are often failures of execution rather than science
• Applying real-world operational evidence to trial design decisions before problems surface
• Identifying execution risks early to design more predictable, scalable trials
• Including a live demonstration of Aika, Biorce’s AI-driven clinical trials assistant

• What changes for sponsors when EHDS, eIDAS 2.0 wallets, the Data Governance Act and the AI Act converge on clinical trial data infrastructure.
• Why current consent and audit-trail architectures will not survive a participant’s right to revoke or port their data, and what the Nordic region is already building as the working answer: consent evidence ledgers, privacy-preserving computation, and neutral data altruism intermediaries